Evaluation of OE-MRI in Patients With H&N Cancer

NCT ID: NCT04724096

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-04

Study Completion Date

2023-02-01

Brief Summary

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Assessment of the use of oxygen enhanced MRI scanning in a cohort of patients with head and neck squamous cell carcinomas to identify areas of hypoxia with tumours and relate this to treatment outcomes.

Detailed Description

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Oxygen-enhanced MRI (OE-MRI) is a technique being actively investigated for imaging hypoxia within cancer tissues. Preliminary clinical data demonstrates the feasibility of using this methodology to study patients with head and neck squamous cell carcinoma (HNSCC). The investigators wish to investigate using this methodology to identify hypoxic subvolumes within HNSCC that may have greater resistance to standard radiotherapy treatment and investigate the association of such hypoxic regions with treatment outcomes.

Conditions

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Head and Neck Squamous Cell Carcinoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-patient volunteers

5 non-patient volunteers for testing of protocol to allow for the ascertaining of good quality data prior to the scanning of patients.

Oxygen Enhanced MRI scan

Intervention Type DIAGNOSTIC_TEST

Dynamic MRI scanning switching from breathing room air to high concentration oxygen part way through the scan.

Patients

50 patients to be scanned with the oxygen enhanced MRI scan protocol prior to definitive curative intent therapy.

Oxygen Enhanced MRI scan

Intervention Type DIAGNOSTIC_TEST

Dynamic MRI scanning switching from breathing room air to high concentration oxygen part way through the scan.

Interventions

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Oxygen Enhanced MRI scan

Dynamic MRI scanning switching from breathing room air to high concentration oxygen part way through the scan.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age 18 years and above
* Signed written informed consent


* Histologically proven or strong clinical suspicion of squamous cell carcinoma of the head and neck
* Suitable for undergoing radical radiotherapy or chemoradiotherapy according to local protocols within the head and neck Cancer MDT
* Age 18 years and above
* Adequate physical fitness (WHO performance status 0 to 2)
* Signed written informed consent

Exclusion Criteria

* Contraindications to MRI scans as identified following completion of the Nottingham University Hospitals NHS Trust (NUH) standard MR safety screening protocol
* Severe Chronic Obstructive Pulmonary Disease (COPD) who are at risk of type 2 respiratory failure or require supplemental oxygen
* Volunteers who are pregnant as identified through the NUH standard MR safety screening protocol


* Poor physical fitness (WHO performance status greater than 2)
* Contraindications to MRI scans as identified following completion of the NUH standard MR safety screening protocol
* Severe Chronic Obstructive Pulmonary Disease (COPD) who are at risk of type 2 respiratory failure or require supplemental oxygen
* Patients who are pregnant or breast-feeding (due to IV contrast use in the routine clinical scan) as identified through the NUH standard MR safety screening protocol
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nottingham University Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rafal Panek, PhD

Role: PRINCIPAL_INVESTIGATOR

Nottingham University Hospitals NHS Trust

Locations

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Queens Medical Centre

Nottingham, Nottinghamshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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McCabe A, Martin S, Rowe S, Shah J, Morgan PS, Borys D, Panek R. Oxygen-enhanced MRI assessment of tumour hypoxia in head and neck cancer is feasible and well tolerated in the clinical setting. Eur Radiol Exp. 2024 Mar 6;8(1):27. doi: 10.1186/s41747-024-00429-1.

Reference Type DERIVED
PMID: 38443722 (View on PubMed)

Other Identifiers

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20MP001

Identifier Type: -

Identifier Source: org_study_id

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